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Turbett Surgical Container, TS1000: Indicated for enclosing… recallZ-1038-2023 · Turbett Surgical, Inc. · initiated Dec 5, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Turbett Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.

FDA root cause category: Device Design

What the company is doing

***UPDATE*** Turbett Surgical issued via E-mails Product Alert directly to the Hospital departments utilizing the device on 12-27-2022. Letter states reason for recall, health risk and action to take: Actions to be taken by the Customer/User: 1. Immediately discontinue the use of the specific devices exhibiting one or more failure(s) listed below. " Missing side supports " Broken or cracked side tab support " Backwall weld separation " Side weld separation " Crack in the backwall seam 2. Email ([email protected]) with the following information. " Hospital name " Serial number(s) " Type of failure that your container exhibited 3. Turbett Surgical will contact you to organize pick up of the damaged unit and shipment of a replacement unit. If your container does not exhibit any of these failures, please continue to monitor and inspect the condition of the container and follow the Instructions For Use (IFU) as you continue utilizing your container. 4. If your container does not exhibit any of these failures, please email [email protected] stating that your container(s) do not exhibit any of these failures. Please continue to monitor and inspect your devices prior to assembling for sterilization AS WELL AS after sterilization and cooling to ensure expected outcomes. Reminder to follow the Instructions For Use (IFU) as you continue utilizing your TS-1200 container. If you have any questions about the content of this letter, please contact Mark Petras at [email protected]. ________________________________________________________________________ Turbett Surgical issued Emails to the Hospital department on 12/7/2022. Sales representatives were notified on 12/5/22 to switch out the other container. Letter states reason for recall, health risk and action to take: 1. Immediately verify that the specific serial numbered devices listed below, continues to operate without creating wet loads or the sterilization process is not compromised.

Recall details

Recall number
Z-1038-2023
Status
Open, Classified
Initiated by the company
Dec 5, 2022
Posted by the FDA
Jan 30, 2023
Recalling firm
Turbett Surgical, Inc.
Quantity
6 units
Product code
FRG
FDA submissions
K153025
Distribution
US Nationwide distribution in the states of CA, IA, IN, NC, NH, NY, OH, LA, SD, TX, VA, WI.

Product description

Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider

Code information (models, lots, serial numbers)

GTIN: 00859464007212 Lot Number: All Lot Numbers Serial Number: All Serial Numbers

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 91314).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page